FDA 483 - Chemcor Chemical Corp - August 31, 2022

An FDA inspection of Chemcor Chemical Corp in Chino, CA, a manufacturer of OTC drug products, revealed significant deficiencies across its manufacturing operations. The firm lacked adequate written procedures for production and process controls, including validations and equipment qualification, and failed to establish a functional quality control unit. Additionally, laboratory controls were insufficient, and components were not handled or stored to prevent contamination.